The Federal Needlestick Safety and Prevention Act:

• Sets forth in greater detail requirements for employers to identify, evaluate, and implement safety-engineered medical devices.
• Requires the maintenance of a sharps injury log
• Mandates involvement of non-managerial employees in evaluating safety devices.

In 2002, all medical practices and facilities should be using safety devices whose safety feature is integral to the device.

As of April 1, 2002, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) will require full compliance with the new Bloodborne Pathogen Standard, including the use of safety devices, in order to receive accreditation.

The Act applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM), including:

• Hospitals
• Surgery Centers
• Medical Clinics
• Physician offices
• Nursing homes
• Home Care/ Home Infusion

Since the law was passed, OSHA officials have inspected all types of healthcare facilities, and have issued citations and fines to those not in compliance. This has included hospitals, physician practices, surgery centers and nursing homes.

Each citation can lead to a fine of up to $7,000. "Willful" violations can lead to fines as high as $70,000. Failure to use a safety product, such as blunt tipped suture needles where applicable, can lead to multiple citations, which could include:

• Failure to document evaluation and use of the safety product in the Exposure Control Plan.
• Failure to include involvement of exposed employees in the evaluation and selection of safety products.
• Failure to implement safety products.

OSHA intends to prevent occupational injuries, exposures and illnesses.

Employers also must investigate availability of safety devices each year, and document that fact in their Exposure Control Plan. If a safer device is available, but back ordered or delayed, this must be documented. The device must be implemented as soon as it becomes available, and documented.

This judgment will likely be challenged since OSHA has already collected data from across the country demonstrating that safety-engineered devices do effectively reduce needlesticks. Deciding not to use safety devices needs to be based on clinical justifications that are clearly documented in the Exposure Control Plan. In the absence of such clinical evidence, employers are expected to adopt available safety devices.

Before passing the Needlestick Act, OSHA conducted an industry-wide cost/benefit analysis and concluded that the use of safety medical devices was beneficial due to the reduction in expenses associated with testing and treating injured healthcare workers. For example, workup and prophylaxis of a high-risk exposure to HIV can cost as much as $3500. Moreover, $500,000 to $1,000,000 may be spent to treat a worker who contracts hepatitis C or HIV.

No. The Law requires employees to use safety devices in all cases where safer medical devices are available.

No. OSHA does not approve or endorse any product. It is your responsibility as an employer to determine which engineering controls are appropriate for specific hazards, based on what is appropriate to the specific medical procedures being conducted, what is feasible, and what is commercially available. For more information on blunt sutures, see Advanced Precautions for today’s OR.

The BBP standard applies to all workplaces, regardless of size, as not only are the practicing physicians at risk of needlesticks, but also those employees working with them and downstream.

If your practice has 10 or more employees, you must maintain a sharps injury log for recording injuries from contaminated sharps. The Sharps Log must detail the injury, the type and brand of device involved in the injury (if known), the department or work area where the exposure occurred, and an explanation of how the incident occurred. The log must protect the confidentiality of the injured employee.

In addition to what is already required by the 1991 standard, the revised standard requires the documentation of annual consideration and implementation of appropriate engineering controls, and solicitation of non-managerial workers in evaluating devices. The plan must be reviewed and updated every year.

States with state OSHA programs were required to adopt the revised standard by Oct. 18, 2001. States may choose to implement their own, more stringent standards independently of the Needlestick Act.

Employers should read the OSHA Bloodborne Pathogens Standard and the Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, which can be obtained at http://www.osha.gov or by phone at 1-800-321-OSHA. The National Institute for Occupational Safety and Health (NIOSH) and the Centers for Disease Control and Prevention (CDC) also have documents related to the prevention of occupational exposure to blood and OPIM.